Executive-QA

Overview

The Executive-QA role supports pharmaceutical laboratory quality assurance by reviewing records and procedures, conducting inspections and audits, maintaining regulatory compliance, training staff, and handling investigations and corrective actions.

What you'll do

• Review analysis records, MOA and SOPs to ensure compliance with GMP and regulatory requirements.
• Approve or reject procedures or specifications impacting the identity, strength, quality, and purity of the drug product or drug substance.
• Review qualification and calibration records through hard copy and electronic data.
• Review software qualification documents, including IQ, OQ, and user acceptance testing.
• Perform inspections of laboratory areas to ensure procedures and conditions are consistent with GMP/GLP standards.
• Conduct internal audits of systems, processes, and documentation to identify non-conformances and areas for improvement.
• Participate in regulatory inspections and audits conducted by health authorities.
• Independently handle customer audits and defend established policies.
• Investigate cited non-compliances, prepare compliance reports, and implement corrective and preventive actions.
• Provide training to staff on GMP, SOPs, regulatory requirements, and updates.
• Ensure personnel are adequately trained in their roles and maintain competency in performing their tasks.
• Maintain up-to-date knowledge of pharmaceutical regulations and industry standards.
• Monitor new and existing guidance and regulation updates.
• Devise new policies and systems, based on applicability, to make the laboratory compliant with prevailing regulations.
• Update or implement policies and procedures to maintain laboratory compliance.
• Aid investigations of deviations, non-conformances, or complaints related to product quality.
• Facilitate the implementation of CAPA to address issues and prevent recurrence.
• Document findings, results, and corrective actions in accordance with regulatory requirements.
• Approve laboratory investigations, change control, and hypothesis testing plans for OOS investigations.

Details

• Location: Navi Mumbai, India.